Cleared Traditional

K011478 - I-STAT SYSTEM

K011478 is an FDA 510(k) clearance for I-STAT SYSTEM, manufactured by I-Stat Corp.. The device is a Class 1 Chemistry device with product code KHP cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K011478 · I-Stat Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
49d
Days
Class 1
Risk

K011478 is an FDA 510(k) clearance for the I-STAT SYSTEM. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on July 2, 2001 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1450 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011478

510(k) Number K011478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date July 02, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 89d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

KHP Device Classification - Class 1, General Controls

Product Code KHP Acid, Lactic, Enzymatic Method
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KHP Acid, Lactic, Enzymatic Method

All 26
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K011478.
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
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IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
K013938 · Diametrics Medical, Inc. · Jan 2002
LACTATE PRO SYSTEM
K980908 · Kdk Corp. · Sep 1998
I-STAT LACTATE TEST
K982071 · I-Stat Corp. · Jun 1998
LACTEST I
K971944 · Jwt, Inc. · Dec 1997
K011478 · I-STAT SYSTEM
Download PDF FDA Summary I-Stat Corp.